American Journal of Clinical Pathology · 2019 · 37 citations · 17 references
PharmacyCardiologyBioinstrumentationBiopharmaceuticsPreventive CardiologyBioanalytical Method ValidationCardiac BiomarkersAvidin-biotin Affinity SystemsBiotin-streptavidin ImmobilizationCardiac TroponinsHigh-sensitivity Troponin AssaysInterferenceMyocardial Injury DetectionMyocardial Injury MarkersTroponin Elevation
OBJECTIVES: To investigate biotin interference on three cardiac troponin (cTn) assays and demonstrate a method to overcome biotin interference. METHODS: cTn levels were measured in (1) plasma from healthy volunteers on 10-mg daily biotin supplementation mixed with a plasma with known elevated troponin, (2) plasmas with known elevated cTn after mixing in reagent biotin to simulate supplementation, and (3) biotin-spiked plasma specimens pretreated with streptavidin-agarose beads. RESULTS: Daily biotin ingestion (10 mg) and studies simulating daily biotin use resulted in significant interference in the Gen5 cardiac troponin T (cTnT) assay; the contemporary Gen 4 cTnT and high-sensitivity cardiac troponin I (hs-cTnI) assays were unaffected. The biotin interference threshold was 31, 315, and more than 2,000 ng/mL for Gen5 cTnT, cTnT, and hs-cTnI assays, respectively. Streptavidin pretreatment blocked biotin interference in cTn assays. CONCLUSIONS: Biotin interference is possible at plasma concentrations achievable by ingestion of over-the-counter supplements that may lead to delayed or missed diagnosis of myocardial injury with the Gen5 cTnT assay.
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Analytical Validation of a High-Sensitivity Cardiac Troponin T Assay
Evangelos Giannitsis, Kerstin Kurz, Klaus Hallermayer et al. · Clinical Chemistry · 2009 · 1.1K citations · Full text
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